Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Rare Cancer

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00002515

Collaborator

(none)

Location

150

Duration (Months)

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bone marrow transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with thiotepa, carboplatin, and topotecan followed by bone marrow transplantation in treating patients who have metastatic or progressive rare cancer.

Condition or Disease	Intervention/Treatment	Phase
Childhood Germ Cell Tumor Extragonadal Germ Cell Tumor Head and Neck Cancer Kidney Cancer Liver Cancer Lymphoma Neuroblastoma Ovarian Cancer Retinoblastoma Sarcoma Testicular Germ Cell Tumor	Biological: filgrastim Drug: carboplatin Drug: thiotepa Drug: topotecan hydrochloride Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support Procedure: in vitro-treated bone marrow transplantation	Phase 2

Detailed Description

OBJECTIVES:

Improve the long term disease-free survival of patients with rare cancers at high risk for lethal relapse by using myeloablative chemotherapy with thiotepa, carboplatin, and topotecan followed by autologous bone marrow or peripheral blood stem cell rescue.

OUTLINE: Autologous bone marrow or peripheral blood stem cells (PBSC) are harvested. Patients receive high-dose thiotepa IV over 3 hours on days -8 to -6, carboplatin IV over 4 hours on days -5 to -3, and topotecan IV over 30 minutes on days -8 to -4. Autologous bone marrow or PBSC are reinfused on day 0. Patients receive filgrastim (G-CSF) IV twice daily beginning on day 1.

Patients are followed for 1 year.

PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study within 5 years.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

Myeloablative Chemotherapy With Bone Marrow Rescue For Rare Poor-Prognosis Cancers

Study Start Date :

Oct 1, 1992

Actual Primary Completion Date :

Apr 1, 2005

Actual Study Completion Date :

Apr 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed malignancy of one of the following types:
Wilms' tumor
Liver cancer
Desmoplastic or other small round cell tumor
Nasopharyngeal carcinoma
Fibrosarcoma
Disease that has metastasized and has a cure rate of no greater than 25% with conventional treatment or disease that has progressed after prior chemotherapy, was not then surgically resectable, and has a salvage rate with nonmyeloablative therapies of no greater than 25% required
Maximal benefit from conventional (nonmyeloablative) doses of combination chemotherapy required prior to entry, and it is recommended that patients have received a minimum of one of the following:
2 courses of high-dose cyclophosphamide (as per protocol MSKCC-90062)
2 courses of high-dose ifosfamide/etoposide (as in the poor-risk sarcoma protocol MSKCC-90071A)
1 course of high-dose cyclophosphamide plus 1 course of high-dose ifosfamide/etoposide
Within 3 weeks of initiation of protocol therapy, patients must be:
In CR or good PR OR
Tumor considered "chemosensitive", i.e., a 50% or greater decrease in at least 1 measurable tumor parameter attributable to prior chemotherapy without evidence of progressive disease by any other parameter
Ineligible for other IRB-approved myeloablative regimens
No evidence of current bone marrow involvement on bone marrow aspiration (x4) and biopsy (x2)